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Efficacy and Safety of Diazep...

Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

NCT ID: NCT00319501

Last Updated: 2016-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2014-07-31

Brief Summary

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To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.

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Detailed Description

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Conditions

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Seizures Epilepsies, Partial Epilepsy, Complex Partial Epilepsy, Generalized Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intramuscular autoinjector; administered at onset of an episode

Diazepam

During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.

Group Type EXPERIMENTAL

Vanquix Auto-Injector (Diazepam Injection)

Intervention Type DRUG

Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode

Interventions

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Placebo

Intramuscular autoinjector; administered at onset of an episode

Intervention Type DRUG

Vanquix Auto-Injector (Diazepam Injection)

Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For Patient:

* Older than 2 years of age and between 6 and 136 kg body weight
* Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ARS)
* Experienced at least 2 episodes of ARS in previous year, one of which occurred in previous 6 months
* Has episodes of ARS that include complex partial or generalized seizures
* Has a responsible caregiver available to participate
* Is not pregnant or lactating and is practicing an acceptable method of birth control.

For Caregiver:

* Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:

* Recognize an episode of repetitive seizures for which the injection was intended,
* Administer study drug
* Count and record seizures and respiratory rate in the patient diary,
* Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
* Recognize the need for immediate medical attention.

Exclusion Criteria

For Patient:

* Petit mal status or petit mal variant status
* History of ARS consistently progressing to status epilepticus
* History of failure to respond to benzodiazepine treatment
* Hypersensitivity to diazepam
* Acute narrow angle glaucoma
* Alcohol and/or other substance abuse
* Has taken another investigational drug in previous 30 days
* Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Neurology Clinic, PC

Northport, Alabama, United States

Site Status

Clinical Trials, Inc

Little Rock, Arkansas, United States

Site Status

Stein Life Child Neurology Medical Specialists Inc.

Irvine, California, United States

Site Status

Collaborative NeuroScience Network, LLC

Long Beach, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status